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Severe Sepsis/Septic Shock on Admission to the General Surgical ICU

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Mahidol University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01363635
First received: May 28, 2011
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

Severe sepsis/septic shock are serious complications of infection with high morbidity and mortality. Recent information showed that early and aggressive resuscitation with goal directed therapy help improving survival and outcome especially the resuscitation within the first 6 hours. In surgical patients, either severe sepsis/septic shock bought them to the operating room or this sepsis might be found after surgery resulting in higher morbidity and mortality. Not only knowledge management, others possible risk factors should also be identified and corrected for outcome improving. This prospective observational study will be done in 800 adult surgical patients admitting to the general surgical intensive care unit. Incidence of severe sepsis/septic shock on admission along with risk factors associated with poor outcomes [organ failure (AKI, ALI, PMI, liver failure, stroke), prolonged ICU length of, stay, ICU death] will be recorded especially effect of amount and type of fluid replacement in the first 6 hours, 24, 48 and 72 hours after diagnosis. Knowledge about severe sepsis/septic shock was implemented among the associated personal, outcome as major organ failure, ICU length of stay, ICU death will also be compare between this prospective study and historical controlled.


Condition
Septic Shock
Multiple Organ Failure
Fatal Outcome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Severe Sepsis/Septic Shock on Admission to the General Surgical ICU

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • incidence of severe sepsis/septic shock on admission to the general surgical ICU [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: June 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
severe sepsis
severe sepsis/septic shock, organ failure, ICU death

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult surgical patient admiitiing to the general surgical ICU

Criteria

Inclusion Criteria:

  • Adult (> 18 years) surgical patient admitting to the general surgical ICU
  • Consent to this study

Exclusion Criteria:

  • Patient undergoing cardiothoracic surgery, neurosurgery and traumatic surgery
  • Not consent to this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363635

Contacts
Contact: Suneerat Kongsayreepong, MD (661) 8427419 sisko@mahidol.ac.th
Contact: Onuma Chaiwat, MD (664)-3882104 sioca@mahidol.ac.th

Locations
Thailand
ICU Siamitra and ICU salad-Sumang, Deaprtment of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand Not yet recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Suneerat Kongsayreepong, MD    (661) 8427419    sisko@mahidol.ac.th   
Contact: Onuma Chailwat, MD    (664)-3882104    sioca@mahidol.ac.th   
Principal Investigator: Suneerat Kongsayreepong, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Suneerat Kongsayreepong, MD Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol University, Bnagkok, Thailand
  More Information

Publications:
Responsible Party: Prof. Suneerat Kongsayreepong, MD, Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol University,Bangkok, Thailand
ClinicalTrials.gov Identifier: NCT01363635     History of Changes
Other Study ID Numbers: Si199/2011
Study First Received: May 28, 2011
Last Updated: June 2, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
severe sepsis/septic shock
organ failure
AKI
PMI
ALI
Stroke
ICU death

Additional relevant MeSH terms:
Multiple Organ Failure
Shock
Shock, Septic
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 25, 2014